SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
March 21, 2012
Commission File Number: 0-29374
EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ x] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
This report on Form 6-K is hereby incorporated by reference in the following registration statements of EDAP TMS S.A. on Form F-3: file number 333-136811, 333-169793, 333-177224 and 333-179689.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: March 21, 2012
EDAP TMS S.A.
/s/ MARC OCZACHOWSKI
MARC OCZACHOWSKI
CHIEF EXECUTIVE OFFICER
EDAP Fourth Quarter and Full Year 2011 Results
Fourth Quarter 2011 Results
EDAP TMS SA (“EDAP” or the “Company”) had total consolidated revenue for the fourth quarter 2011 was EUR 7.5 million (USD 10.1 million), a 6% decrease compared to EUR 8.0 million (USD 10.8 million) for the fourth quarter 2010 and a 23% increase compared to EUR 6.1 million (USD 8.6 million) for the third quarter 2011.
Total revenue for the HIFU division was EUR 1.8 million (USD 2.4 million) for the fourth quarter 2011, compared to EUR 2.0 million (USD 2.6 million) for the same period last year. Results for the fourth quarter 2011 reflected the sale of one Ablatherm-HIFU device, as compared to two devices sold in the same period last year.
For the three months ended December 31, 2011, total revenue for the lithotripsy division was EUR 5.8 million (USD 7.8 million), compared to EUR 6.1 million (USD 8.1 million) during the year ago period. During the fourth quarter 2011, the Company recorded sales of sixteen lithotripsy machines, comprised of seven Sonolith i-move devices, five Sonolith i-sys devices and four Sonolith Praktis devices, compared to a total of twenty devices sold in the fourth quarter of 2010.
Gross profit for the fourth quarter 2011 was EUR 2.8 million (USD 3.8 million), compared to EUR 3.0 million (USD 4.0 million) for the year ago period. Gross profit margin was 37.2% in the fourth quarter 2011, largely stable compared to 37.6% in the year ago period.
Operating expenses were EUR 3.2 million (USD 4.3 million) for the fourth quarter 2011, down 7% from EUR 3.4 million (USD 4.6 million) for the same period in 2010. Operating loss was EUR 371,000 (USD 499,000) for the fourth quarter 2011, compared to EUR 371,000 (USD 496,000 million) in the fourth quarter of 2010. Excluding operating expenses of EUR 154,000 (USD 207,000) associated with the U.S. FDA ENLIGHT clinical trial for Ablatherm-HIFU, fourth quarter 2011 operating loss was EUR 217,000 (USD 292,000).
Net loss for the fourth quarter 2011 was EUR 579,000 (USD 779,000), or EUR 0.04 per diluted share (USD 0.06 per diluted share), as compared to net loss for the fourth quarter of 2010 of EUR 7.2 million (USD 9.7 million), or EUR 0.56 per diluted share (USD 0.74 per diluted share). Net income for the fourth quarter 2011 included a non-cash interest expense of EUR 23,000 to adjust the Company’s outstanding convertible debt and warrants to fair market value.
At December 31, 2011, cash and cash equivalents, including short-term treasury investments, were EUR 6.5 million (USD 8.4 million), which reflected the stabilization of Company’s cash position. The Company was cash flow positive during the fourth quarter 2011 and generated EUR 1.0 million as a result of strong cash management.
Full Year 2011 Results
EDAP’s total consolidated revenue for the full year ended December 31, 2011 was EUR 22.3 million (USD 31.2 million), as compared to EUR 23.7 million (USD 31.3 million) for the full year 2010. The 2011 revenue included the sale of 40 lithotripsy devices that featured a higher average selling price due to product innovation.
Gross profit for the full year 2011 was EUR 8.9 million (USD 12.4 million) and operating loss was EUR 2.5 million (USD 3.5 million), compared to EUR 9.5 million (USD 12.5 million) and EUR 3.8 million (USD 5.0 million), respectively, for the same period 2010. The revenue shift was reflected in the lower gross profit, but was more than offset by reductions in operating expenses, which were EUR 11.4 million (USD 15.9 million) for the full year 2011, compared to EUR 13.3 million (USD 17.5 million) for the same period 2010.
Net loss for the full year 2011 was EUR 939,000 (USD 1.3 million), or EUR 0.07 per diluted share. The full year 2011 net loss included a non-cash interest income of EUR 2.4 million (USD 3.4 million) to adjust the Company’s convertible debt and outstanding warrants to fair value, and to reduce the outstanding convertible debt.
Recent Developments
In January 2012, EDAP streamlined its capital structure by exchanging its outstanding convertible debt and warrants for USD 10.0 million 9% non-convertible term notes due June 30, 2014.
In December 2011, EDAP installed its second Sonolith i-move lithotripter at USC Medical Center in Los Angeles and UC San Diego following the receipt of the US 510 clearance in August 2011 and expanded its U.S. sales pipeline to include a third device in its backlog that is on track to be delivered and installed in the first half of 2012.
In February 2012, EDAP’s Ablatherm-HIFU was featured in seven poster presentations supporting its efficacy for the treatment of localized prostate cancer at the 27th Annual European Association of Urology (EAU) Congress held in Paris, France. The comprehensive data validates the international urology community’s support for Ablatherm-HIFU as a complement to surgery in addressing prostate cancer and EDAP’s proven ability to bring minimally invasive treatment to younger patients seeking effective treatments that afford quality of life preservation.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are based on management's current expectations and are subject to a number of uncertainties, including the uncertainties of the regulatory process, and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections “Cautionary Statement on Forward-Looking Information” and “Risk Factors” in the Company’s Annual Report on Form 20-F. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
EDAP TMS S.A.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
|
Three Months Ended:
|
Three Months Ended:
|
|||||||||||||||
|
December 31,
2011
Euros
|
December 31,
2010
Euros
|
December 31,
2011
$US
|
December 31,
2010
$US
|
|||||||||||||
| Sales of medical equipment | 4.924 | 5,671 | 6,626 | 7,599 | ||||||||||||
|
Net Sales of RPP and Leases
|
1,213 | 1,064 | 1,632 | 1,426 | ||||||||||||
|
Sales of spare parts, supplies and Services
|
1,394 | 1,302 | 1,877 | 1,745 | ||||||||||||
|
TOTAL NET SALES
|
7,531 | 8,037 | 10,134 | 10,769 | ||||||||||||
|
Other revenues
|
(7 | ) | 1 | (10 | ) | 1 | ||||||||||
|
TOTAL REVENUES
|
7,523 | 8,038 | 10,124 | 10,770 | ||||||||||||
|
Cost of sales
|
(4,725 | ) | (5,013 | ) | (6,358 | ) | (6,717 | ) | ||||||||
|
GROSS PROFIT
|
2,798 | 3,025 | 3,766 | 4,053 | ||||||||||||
|
Research & development expenses
|
(591 | ) | (675 | ) | (795 | ) | (904 | ) | ||||||||
|
S, G & A expenses
|
(2,579 | ) | (2,721 | ) | (3,470 | ) | (3,646 | ) | ||||||||
|
Total operating expenses
|
(3,170 | ) | (3,396 | ) | ( 4,265 | ) | (4,550 | ) | ||||||||
|
OPERATING PROFIT (LOSS)
|
(371 | ) | (371 | ) | (499 | ) | (496 | ) | ||||||||
|
Interest (expense) income, net
|
(233 | ) | (6,851 | ) | (313 | ) | (9,180 | ) | ||||||||
|
Currency exchange gains (loss), net
|
287 | 81 | 386 | 109 | ||||||||||||
|
Other income (loss), net
|
3 | 2 | 5 | 3 | ||||||||||||
|
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST
|
(313 | ) | (7,138 | ) | (422 | ) | (9,565 | ) | ||||||||
|
Income tax (expense) credit
|
(266 | ) | (86 | ) | (357 | ) | (115 | ) | ||||||||
|
NET INCOME (LOSS)
|
(579 | ) | (7,224 | ) | (779 | ) | (9,680 | ) | ||||||||
|
Earning per share – Basic
|
(0.04 | ) | (0.56 | ) | (0.06 | ) | (0.74 | ) | ||||||||
|
Average number of shares used in computation of EPS
|
13,345,004 | 13,008,401 | 13,345,004 | 13,008,401 | ||||||||||||
|
Earning per share – Diluted
|
(0.04 | ) | (0.56 | ) | (0.06 | ) | (0.74 | ) | ||||||||
|
Average number of shares used in computation of EPS for positive net income
|
13,317,115 | 13,496,394 | 13,317,115 | 13,496,394 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2011 average three months noon buying rate of 1 Euro = 1.3457USD, and 2010 average three months noon buying rate of 1 Euro = 1.3399 USD.
| Twelve Months Ended: | Twelve Months Ended: | |||||||||||||||
|
December 31,
2011
Euros
|
December 31,
2010
Euros
|
December 31,
2011
$US
|
December 31,
2010
$US
|
|||||||||||||
|
Sales of medical equipment
|
12,399 | 13,135 | 17,361 | 17,358 | ||||||||||||
|
Net Sales of RPP and Leases
|
4,508 | 4,689 | 6, 312 | 6,197 | ||||||||||||
|
Sales of spare parts, supplies and Services
|
5,365 | 5,378 | 7,511 | 7,107 | ||||||||||||
|
TOTAL NET SALES
|
22,272 | 23,202 | 31,184 | 30,662 | ||||||||||||
|
Other revenues
|
20 | 506 | 28 | 669 | ||||||||||||
|
TOTAL REVENUES
|
22,292 | 23,708 | 31,212 | 31,331 | ||||||||||||
|
Cost of sales
|
(13,435 | ) | (14,253 | ) | (18,811 | ) | (18,836 | ) | ||||||||
|
GROSS PROFIT
|
8,857 | 9,455 | 12,401 | 12,495 | ||||||||||||
|
Research & development expenses
|
(2,436 | ) | (3,268 | ) | (3,411 | ) | (4,318 | ) | ||||||||
|
S, G & A expenses
|
(8,917 | ) | (10,005 | ) | (12,486 | ) | (13,222 | ) | ||||||||
|
Total operating expenses
|
(11,353 | ) | (13,272 | ) | (15,897 | ) | (17,540 | ) | ||||||||
|
OPERATING PROFIT (LOSS)
|
(2,497 | ) | (3,818 | ) | (3,496 | ) | (5,045 | ) | ||||||||
|
Interest (expense) income, net
|
1,522 | (8,844 | ) | 2,131 | (11,688 | ) | ||||||||||
|
Currency exchange gains (loss), net
|
482 | 884 | 675 | 1,168 | ||||||||||||
|
Other income (loss), net
|
(50 | ) | - | (70 | ) | - | ||||||||||
|
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST
|
(543 | ) | (11,778 | ) | (761 | ) | (15,565 | ) | ||||||||
|
Income tax (expense) credit
|
(395 | ) | (939 | ) | (553 | ) | (1,241 | ) | ||||||||
|
NET INCOME (LOSS)
|
(938 | ) | (12,717 | ) | (1,314 | ) | (16,806 | ) | ||||||||
|
Earning per share – Basic
|
(0.07 | ) | (0.98 | ) | (1.10 | ) | (1.29 | ) | ||||||||
|
Average number of shares used in computation of EPS
|
13,345,004 | 13,008,401 | 13,345,004 | 13,008,401 | ||||||||||||
|
Earning per share – Diluted
|
(0.07 | ) | (0.98 | ) | (1.10 | ) | (1.29 | ) | ||||||||
|
Average number of shares used in computation of EPS for positive net income
|
13,353,985 | 13,094,235 | 13,353,985 | 13,094,235 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2011 average twelve months noon buying rate of 1 Euro = 1.4002 USD, and 2010average twelve months noon buying rate of 1 Euro = 1.3215 USD.
EDAP TMS S.A.
CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
(Amounts in thousands of Euros and U.S. Dollars)
|
Dec. 31,
2011
Euros
|
Sept. 30,
2011
Euros
|
Dec. 31,
2011
$US
|
Sept. 30,
2011
$US
|
|||||||||||||
|
Cash, cash equivalents and short term investments
|
6,472 | 5,482 | 8,396 | 7,373 | ||||||||||||
|
Total current assets
|
26,740 | 25,915 | 34,691 | 34,855 | ||||||||||||
|
Total current liabilities
|
20,757 | 12,530 | 26,930 | 16,853 | ||||||||||||
|
Shareholders’ Equity
|
8,713 | 9,347 | 11,303 | 12,572 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.2974 USD, on December 31, 2011 and at the noon buying rate of 1 Euro = 1.3450 USD, on September 30, 2011.
EDAP TMS S.A.
CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
TWELVE MONTHS ENDED DECEMBER 31, 2011
(Amounts in thousands of Euros)
|
HIFU Division
|
UDS Division
|
FDA Trials
|
Corporate
|
Total After
Consolidation
|
|||||||||||||||||||||||
|
Sales of goods
|
1,442 | 10,957 | 12,399 | ||||||||||||||||||||||||
|
Sales of RPPs & Leases
|
3,270 | 1,238 | 4,508 | ||||||||||||||||||||||||
|
Sales of spare parts & services
|
1,153 | 4,212 | 5,365 | ||||||||||||||||||||||||
|
TOTAL NET SALES
|
5,865 | 16,407 | 22,272 | ||||||||||||||||||||||||
|
Other revenues
|
20 | - | 20 | ||||||||||||||||||||||||
|
TOTAL REVENUES
|
5,885 | 16,407 | 22,292 | ||||||||||||||||||||||||
|
GROSS PROFIT
|
3,264 | 56 | % | 5,592 | 34 | % | 8,857 | 40 | % | ||||||||||||||||||
|
Research & Development
|
(950 | ) | (792 | ) | (694 | ) | (2,436 | ) | |||||||||||||||||||
|
Total SG&A plus depreciation
|
(2,571 | ) | (4,679 | ) | (79 | ) |
(1,588)
|
(8,917 | ) | ||||||||||||||||||
|
OPERATING PROFIT (LOSS)
|
(257 | ) | 122 | (773 | ) |
(1,588)
|
(2,497 | ) | |||||||||||||||||||